BPR Guidance Vol II Part A en

GUIDANCE
Guidance on the Biocidal Products Regulation

Volume II: Efficacy
Part A: Information Requirements
Version 2.0
May 2018
Guidance on the BPR: Volume II Part A
2 Version 2.0 May 2018
LEGAL NOTICE
This document aims to assist users in complying with their obligations under the Biocidal
Products Regulation (BPR). However, users are reminded that the text of the BPR is the
only authentic legal reference and that the information in this document does not
constitute legal advice. Usage of the information remains under the sole responsibility of
the user. The European Chemicals Agency does not accept any liability with regard to the
use that may be made of the information contained in this document
Guidance on the Biocidal Products Regulation: Volume II: Efficacy - Part A:

Information Requirements
Reference: ECHA-18-G-04-EN
Cat. Number: ED-02-18-532-EN-N
ISBN: 978-92-9020-505-0
DoI: 10.2823/510705
Publ. date: May 2018
Language: EN
© European Chemicals Agency, 2018
If you have questions or comments in relation to this document please send them (quote
the reference and issue date) using the information request form. The information
request form can be accessed via the Contact ECHA page at:
http://echa.europa.eu/contact.
European Chemicals Agency
Mailing address: P.O. Box 400, FI-00121 Helsinki, Finland

Visiting address: Annankatu 18, Helsinki, Finland
Version 2.0 May 2018 3
DOCUMENT HISTORY
Version Comment Date
Version 1.0 First edition June 2013
Version 1.1 Corrigendum: November

2014
- Division of the guidance in the 4 volumes of the new BPR
Guidance structure
- Minor editorial changes

Version 2.0 Update to align Part A with Parts B+C: May 2018
 Update to Sections 2 and 3 relating to Point 6 of the

Annexes II and III;
 Addition of sections 2.2 & 3.2 - “Point 7 Intended Uses

and Exposure” from Volume I Part A, and subsequent
update of these sections.
Corrigendum:
 In Preface: To update the text to reflect the changes to
the structure of the BPR guidance and to align the text
with that in the current published Parts B+C for
Volumes II, III and IV;
 In Preface: to add text and links on “Applicability of
Guidance”;
 To amend the formatting and numbering of all sections

for clarification and to include cross reference to Annex
sections
PREFACE
The Guidance on the Biocidal Products Regulation – Part A (information requirements) is
to be applied to applications for active substance approval and product authorisation as
submitted from 1 September 2013, the date of application (DoA) of the Biocidal Product
Regulation (the BPR).
This document describes the BPR obligations and how to fulfil them.
The scientific guidance provides technical scientific advice on how to fulfil the information
requirements set by the BPR, how to perform the risk assessment and the exposure
assessment for the evaluation of the human health and environmental aspects and how
to assess and evaluate the efficacy to establish the benefit arising from the use of
biocidal products and that it is sufficiently effective (Parts B & C).
In addition to the BPR guidance, the Biocidal Products Directive (BPD) guidance and
other related documents are still considered applicable for new submissions under the
BPR in the areas where the BPR guidance is under preparation. Furthermore, these
documents are still valid in relation to the applications for active substance approval or
applications for product authorisation under the BPD that may still be under
evaluation. Also the Commission has addressed some of the obligations in further detail
in the Biocides competent authorities meetings documents which applicants are advised
to consult. Please see ECHA Biocides Guidance website for links to these documents:
[https://echa.europa.eu/guidance-documents/guidance-on-biocides-legislation].
The complete guidance series in support of the BPR is shown in the figure below:
Figure 1: BPR guidance structure

The BPR guidance was developed based on the Technical Notes for Guidance (TNsG) on
data requirements under the previous legislation, the Biocidal Products Directive (BPD).
However, the information requirements compared to the BPD have changed in the BPR;
the major differences are:
1. The term information requirement is used instead of data requirement. The new
term reflects the fact that applicants do not, in all cases, need to supply data, i.e.
information originating from studies but also general information such as
addresses and names as well as (quantitative) structure–activity relationship
(Q)SAR and so forth.
2. The harmonisation with Guidance from other legal frameworks was a key
objective:
a. When applicable, endpoint sections entail a reference to a relevant REACH
(Regulation (EC) No 1907/2006 on Registration, Evaluation, Authorisation
and Restriction of Chemicals) Guidance if available;
b. When applicable, Guidance from the Plant Protection Products Regulation
(PPPR, Regulation (EC) No 1107/2009) – Uniform Principles is referred to.
3. The structure has been modified in accordance with the new BPR Annex
structure:
a. The core data set (CDS) and additional data set (ADS) are listed in the
same section.
b. The specific rules for adaptation from standard information requirements
(including those given by BPR Annex II and III column 3) are included in
the respective endpoint sections, where available.
4. The core data requirements have been modified and certain long term animal
studies are only required when necessary.
5. The BPR also allows for a more systematic approach to the adaptation of
information requirements based on exposure as well as the use of techniques
such as read-across, (Q)SAR and calculation methods.
6. The principle of proposing and accepting adaptations to the information
requirements has been formalised and Member States have to inform and, if
possible, assist the applicants with their adaptation requests.
7. It is possible to provide a reduced data package on a case-by-case basis when
applying for product authorisation, taking into account the nature of the product
and the expected level of exposure.
Applicability of Guidance
Guidance on applicability of new guidance or guidance related documents for active
substance approval is given in the published document “Applicability time of new
guidance and guidance-related documents in active substance approval” available on the
BPC Webpage1 [https://echa.europa.eu/about-us/who-we-are/biocidal-products-
committee] and for applicability of guidance for product authorisation, please see the
CA-document CA-july2012-doc6.2d (final), available on the ECHA Guidance page
[https://echa.europa.eu/documents/10162/23036409/ca-july12-
doc_6_2d_final_en.pdf].
1
Link available under Working Procedures (right column) [https://echa.europa.eu/about-us/who-
we-are/biocidal-products-committee]
Table of Contents
LEGAL NOTICE ................................................................................................... 2

DOCUMENT HISTORY .......................................................................................... 3
PREFACE ........................................................................................................... 4
LIST OF ABBREVIATIONS .................................................................................... 10
1 PART A: INTRODUCTION TO THE GUIDANCE ON INFORMATION REQUIREMENTS .. 12
1.1 GENERAL STRUCTURE OF THE GUIDANCE ON INFORMATION REQUIREMENTS
13
1.1.1 Information requirements in general ................................................. 13
1.1.2 Comparison of BPD-BPR .................................................................. 13
1.1.3 Volume II Part A: Document structure .............................................. 15
1.2 GUIDING PRINCIPLES WITH REGARD TO INFORMATION REQUIREMENTS IN
GENERAL ............................................................................................. 15
1.3 ON THE USE OF ADDITIONAL GUIDANCE DOCUMENTS ............................... 18
1.3.1 Existing biocides Guidance and other relevant documents .................... 18
1.3.2 REACH Guidance ............................................................................ 19
1.3.3 CLP Guidance ................................................................................. 19
1.4 GENERAL GUIDANCE ON GENERATING NEW INFORMATION ......................... 19
1.5 GUIDANCE ON NON-SUBMISSION OF INFORMATION .................................. 22
1.6 TESTING OF METABOLITES AND TRANSFORMATION PRODUCTS .................. 22
1.7 BACKGROUND DOCUMENTS .................................................................... 22
1.8 SOURCES OF TEST METHODS AND STANDARDS ........................................ 24
2 PART A: DOSSIER REQUIREMENTS FOR ACTIVE SUBSTANCES ............................. 26
BPR ANNEX II, TITLE 1, 6 EFFECTIVENESS AGAINST TARGET ORGANISMS ........... 26
2.1 POINT 6 EFFECTIVENESS AGAINST TARGET ORGANISMS ............................ 26
2.1.1 Point 6.1 Function, e.g. fungicide, rodenticide, insecticide, bactericide and
mode of control e.g. attracting, killing, inhibiting ................................ 26
2.1.2 Point 6.2 Representative organism(s) to be controlled and products,
organisms or objects to be protected ................................................ 26
2.1.3 Point 6.3 Effects on representative target organism(s) ........................ 26
2.1.4 Point 6.4 Likely concentration at which the active substance will be used in
products and, where appropriate, in treated articles ........................... 26
2.1.5 Point 6.5 Mode of action (including time delay) .................................. 26
2.1.6 Point 6.6 Efficacy data to support these claims on biocidal products and,
were label claims are made, on treated articles .................................. 27
2.1.7 Point 6.7 Any known limitations on efficacy........................................ 28
2.1.7.1 Point 6.7.1 Information on the occurrence or possible occurrence
of the development of resistance and appropriate management
strategies .............................................................................. 28
2.1.7.2 Point 6.7.2 Observations on undesirable or unintended side-
effects, e.g. on beneficial and other non-target organisms ........... 29
2.2 POINT 7 INTENDED USES AND EXPOSURE ................................................... 29
2.2.1 Point 7.1 Field of uses envisaged for biocidal products and, where
appropriate, treated articles ............................................................. 29
2.2.2 Point 7.2 Product-type(s) .................................................................. 29
2.2.3 Point 7.3 Detailed description of the intended use pattern(s) including in
treated articles ............................................................................... 29
2.2.4 Point 7.4 Users, e.g. industrial, trained professional, professional or general
public (non-professional) ................................................................. 30
2.2.5 Point 7.5 Likely tonnage to be placed on the market per year and, where
relevant, for the intended major use categories .................................. 30
2.2.6 Point 7.6 Exposure data in conformity with Annex VI to this Regulation .. 31
2.2.6.1 Point 7.6.1 Information on human exposure associated with the
intended uses and disposal of the active substance ..................... 31
2.2.6.2 Point 7.6.2 Information on environmental exposure associated with
the intended uses and disposal of the active substance ............... 31
2.2.6.3 Point 7.6.3 Information on exposure of food producing animals and
food and feeding stuffs associated with the intended uses of the
active substance ..................................................................... 31
2.2.6.4 Point 7.6.4 Information on exposure from treated articles including
leaching data (either laboratory studies or model data) ............... 31
3 PART A: DOSSIER REQUIREMENTS FOR BIOCIDAL PRODUCTS .............................. 35
BPR ANNEX III, TITLE 1, 6 EFFECTIVENESS AGAINST TARGET ORGANISMS .......... 35
3.1 POINT 6 EFFECTIVENESS AGAINST TARGET ORGANISMS ............................ 35
3.1.1 Point 6.1 Function, e.g. fungicide, rodenticide, insecticide, bactericide and
mode of control e.g. attracting, killing, inhibiting ................................ 35
3.1.2 Point 6.2 Representative organism(s) to be controlled and products,
organisms or objects to be protected ................................................ 35
3.1.3 Point 6.3 Effects on representative target organisms. .......................... 36
3.1.4 Point 6.4 Likely concentration at which the active substance will be used
.................................................................................................... 36
3.1.5 Point 6.5 Mode of action (including time delay) .................................. 36
3.1.6 Point 6.6 The proposed label claims for the product and, where label claims
are made, for treated articles ........................................................... 37
3.1.7 Point 6.7 Efficacy data to support these claims, .................................. 37
3.1.8 Point 6.8 Any known limitations on efficacy........................................ 38
3.1.8.1 Point 6.8.1 Information on the occurrence or possible occurrence
of the development of resistance and appropriate management
strategies .............................................................................. 38
3.1.8.2 Point 6.8.2 Observations on undesirable or unintended side effects
e.g. on beneficial and other non-target organisms ...................... 39
3.1.9 Point 6.9 Summary and evaluation ................................................... 39
3.2 POINT 7 INTENDED USES AND EXPOSURE................................................. 39
3.2.1 Point 7.1 Field(s) of use envisaged for biocidal products and, where
appropriate, treated articles ............................................................. 40
3.2.2 Point 7.2 Product-type .................................................................... 40
3.2.3 Point 7.3 Detailed description of intended use pattern(s) for biocidal
products and, where appropriate, treated articles ............................... 40
3.2.4 Point 7.4 User e.g. industrial, trained professional, professional or general
public (non-professional) ................................................................. 40
3.2.5 Point 7.5 Likely tonnage to be placed on the market per year and where
relevant, for different use categories ................................................. 40
3.2.6 Point 7.6 Method of application and a description of this method .......... 40
3.2.7 Point 7.7 Application rate and if appropriate, the final concentration of the
biocidal product and active substance in a treated article or in the system
in which the preparation is to be used, e.g. cooling water, surface water,
water used for heating purposes....................................................... 41
3.2.8 Point 7.8 Number and timing of applications, and where relevant, any
particular information relating to geographical location or climatic
variations including necessary waiting periods, clearance times, withdrawal
periods or other precautions to protect human and animal health and the
environment .................................................................................. 41
3.2.9 Point 7.9 Proposed instructions for use .............................................. 42
3.2.10 Point 7.10 Exposure data in conformity with Annex VI of this
Regulation ..................................................................................... 42
3.2.10.1 Point 7.10.1 Information on human exposure associated with
production and formulation, proposed/expected uses and disposal 42
3.2.10.2 Point 7.10.2 Information on environmental exposure associated
with production and formulation, proposed/expected uses and
disposal ................................................................................. 43
3.2.10.3 Point 7.10.3 Information on exposure from treated articles
including leaching data (either laboratory studies or model data) .. 43
3.2.10.4 Point 7.10.4 Information regarding other products that the product
is likely to be used together with, in particular the identity of the
active substances in these products, if relevant, and the likelihood of
any interactions...................................................................... 43
REFERENCES AND BACKGROUND DOCUMENTS ...................................................... 44
APPENDIX 1 CHECK LIST FOR EFFICACY TESTS PRESERVATIVES ............................. 45
Figures
Figure 1: BPR guidance structure ......................................................................... 4
Figure 2: Structure of data/information requirements under the BPD and the BPR. ..... 14
Tables
Table 1: Section of Annex II BPR vs BPR Guidance Volume and section number ......... 9
Table 2: Section of Annex III BPR vs BPR Guidance Volume and section number ........ 9
Table 3 Three-column- structure of BPR information requirements in Annexes II and III
of the BPR. ........................................................................................................ 14
NOTES to the reader:

When reading this document, please note that the text written in italics originates
from the BPR or its Annexes.
The numbering of the requirements corresponds to the numbering in the BPR
Annexes II and III.
Section Finder: The two tables below relate the sections of the BPR Annexes II and
III with the Guidance Volume and section number.
Table 1: Section of Annex II BPR vs BPR Guidance Volume and section number
BPR Guidance Volume + section

Annex II BPR section
number
1. APPLICANT Volume I: Section 2.1
2. IDENTITY OF THE ACTIVE SUBSTANCE Volume I Section 2.2
3. PHYSICAL, CHEMICAL AND TECHNICAL Volume I Section 2.3
PROPERTIES
4. PHYSICAL HAZARDS AND RESPECTIVE Volume I Section 2.4
CHARACTERISTICS
5. METHODS OF DETECTION AND Volume I Section 2.5
IDENTIFICATION
6. EFFECTIVENESS AGAINST TARGET Volume II: Section 2
ORGANISMS
7. INTENDED USES AND EXPOSURE Volume II Section 2.2
8. TOXICOLOGICAL PROFILE FOR Volume III: Section 2.1
HUMANS AND ANIMALS
9. ECOTOXICOLOGICAL STUDIES Volume IV: Section 2.1
10. ENVIRONMENTAL FATE AND Volume IV: Section 2.2
BEHAVIOUR
11. MEASURES TO BE ADOPTED TO Volume I: Section 2.11
PROTECT HUMANS, ANIMALS AND THE
ENVIRONMENT
12. CLASSIFICATION, LABELLING, AND Volume I: Section 2.12
PACKAGING
Table 2: Section of Annex III BPR vs BPR Guidance Volume and section number
BPR Guidance Volume + section

Annex III BPR section
number
1. APPLICANT Volume I: Section 3.1
2. IDENTITY OF THE BIOCIDAL PRODUCT Volume I: Section 3.2
3. PHYSICAL, CHEMICAL AND TECHNICAL Volume I: Section 3.3
PROPERTIES
4. PHYSICAL HAZARDS AND RESPECTIVE Volume I: Section 3.4
CHARACTERISTICS
5. METHODS OF DETECTION AND Volume I: Section 3.5
IDENTIFICATION
6. EFFECTIVENESS AGAINST TARGET Volume II: Section 3.6
ORGANISMS
7. INTENDED USES AND EXPOSURE Volume II: Section 3.2
8. TOXICOLOGICAL PROFILE FOR HUMANS AND Volume III: Section 3.1
ANIMALS
9. ECOTOXICOLOGICAL STUDIES Volume IV: Section 3.1
10. ENVIRONMENTAL FATE AND BEHAVIOUR Volume IV: Section 3.2
11. MEASURES TO BE ADOPTED TO PROTECT Volume I: Section 3.11
HUMANS, ANIMALS AND THE ENVIRONMENT
12. CLASSIFICATION, LABELLING, AND Volume I: Section 3.12
PACKAGING
List of Abbreviations
Standard term Explanation
/ Abbreviation
(Q)SAR (Quantitative) structure activity relationship
ADS Additional data set
ASTM American Society for Testing and Materials
BPC Biocidal Products Committee (ECHA body)
BPD Biocidal Products Directive. Directive 98/8/EC of the European Parliament
and of the Council on the placing on the market of biocidal products
BPR Biocidal Products Regulation. Regulation (EU) No 528/2012 of the
European Parliament and of the Council concerning the making available
on the market and use of biocidal products
CAS Chemical abstract (Service or System)
CDS Core data set
CEN European Committee for Normalisation
CEPE European Committee for Paints and Inks
CIPAC Collaborative International Pesticides Analytic Council Ltd.
CLP Classification, Labelling and Packaging Regulation. Regulation (EC) No
(Regulation) 1272/2008 of the European Parliament and of the Council on
Classification, Labelling and Packaging of substances and mixtures
DG European Commission Directorate General
DoA Date of application
DWD European Drinking Water Directive (Directive 98/83/EC)
EC European Communities or European Commission
eCA Evaluating Competent Authority
EC methods Test Methods as listed in the Test Methods Regulation
ECHA European Chemicals Agency
EEC European Economic Community
EINECS European Inventory of Existing Commercial Chemical Substances
ELINCS European List of (new or notified) Chemical Substances
EN European norm
EPA Environmental Protection Agency
(DK, USA) (of Denmark, or the United States of America)
EPPO/OEPP European and Mediterranean Plant Protection Organization
Emission Scenario Document, Guidance developed under the BPD tailored
ESD
for biocides
EU European Union
FPD Flame photometric detector
g Gram(s)
GC Gas chromatography
GLP Good laboratory practice
ha Hectare(s)
ISBN International standard book number
ISO International Organization for Standardization
ISO International Organization for Standardization
(TC, SC, WG) Technical Committee, Scientific Committee, Working Group
ISSN International standard serial number
IUCLID International Uniform Chemical Information Database
IUPAC International Union for Pure and Applied Chemistry
JRC Joint Research Centre
kg Kilogram(s)
mg Milligram(s)
MOTA Manual of Technical Agreements of the Biocides Technical Meeting
Standard term Explanation

/ Abbreviation
MSCA Member State competent authority
OECD Organisation for Economic Cooperation and Development
Pa Pascal(s)
Plant Protection Products Regulation. Regulation (EC) No 1107/2009 of
PPPR the European Parliament and of the Council of concerning the placing of
plant protection products on the market
PT Product-type
Regulation (EC) No 1907/2006 of the European Parliament and of the
REACH Council concerning the Registration, Evaluation, Authorisation and
Restriction of Chemicals
RSD Relative standard deviation
s Second(s)
SMEs Small and medium-sized enterprises
Technical material
In accordance with FAO manual (FAO, 2010), TC is usually the final
product from preparation of the active substance prior to being formulated
into an end-use product. This may contain a stabiliser and/or anti-caking
TC
or anti-static agents (if required) but no other additives.
TC is usually ≥900 g/kg with solvent(s) removed during synthesis, with
only residual amounts remaining (usually ≤10%) and no solvent added
subsequently.
Test Methods Regulation (EC) No 440/2008 laying down test methods pursuant to the
Regulation REACH Regulation
TGD Technical Guidance Document (EU, 2003)
TNsG Technical Notes for Guidance
UN United Nations
VDI Verein Deutscher Ingenieure (The Association of German Engineers)
WHO World Health Organisation
1 Part A: Introduction to the Guidance on

Information Requirements
Regulation (EU) No 528/2012 of the European Parliament and of the Council (Biocidal
Products Regulation, the BPR) lays down rules and procedures for approval of the active
substances in biocidal products at European Union (EU) level and for the authorisation of
biocidal products in both Member States and at EU level 2. The objective of the BPR is to
improve the functioning of the internal market on biocidal products whilst ensuring a
high level of environmental and both human and animal health protection. In addition,
the BPR removes a number of deficiencies that were identified during the
implementation of Directive 98/8/EC of the European Parliament and of the Council on
the placing on the market of biocidal products (BPD).
Study data and other information must fulfil the minimum requirements whilst being
sufficient to conduct a proper risk and efficacy assessment in order to finally allow for a
decision on the suitability of the substance to be approved or, the product to be
authorised.
The BPR set out rules on information requirements (especially in Articles 6-8). The
information requirements are specified for active substances in Annex II, and for the
respective biocidal products in Annex III (in Title 1 of Annex II and III for chemicals and
Title 2 of Annex II and III for micro-organisms).
Due to the wide scope of the BPR and the extensive variation of efficacy, exposure and
risks of biocidal products, the general rules provided in the BPR and its Annexes have to
be specified in order to ensure efficient and harmonised day-to-day implementation of
the regulation. The aim of the Guidance is to provide detailed and practical direction on
which study data and other information should be submitted, when applying for approval
and authorisation according to the BPR. The requirements outlined in this Volume are
also applicable for the simplified authorisation procedure, i.e. those products that fulfil all
conditions of the requirements listed in Article 25 of the BPR.
It should be noted that only chemical biocidal products (Title 1 of Annex III to the BPR),
including treated articles, and chemical active substances (Title 1 of Annex II to the BPR)
are covered by the present document. Guidance on the information requirements for
micro-organisms will be available separately in Guidance on micro-organisms (Volume
V). Guidance on substances of concern will be available in Parts B+C of Volumes III and
IV.
Several documents published by the Commission and ECHA have been used as a basis
for the information requirements presented; see section 1.3 of the BPR Guidance,
Volume I, Part A: Information Requirements.
This Guidance is primarily addressed to applicants, seeking approval of an active
substance and for authorisation of a biocidal product, who submit information to the
Member State competent authorities (MSCA). The MSCAs task is then to validate and
evaluate the application, (adequacy and relevance) of the submitted information.
2
The terms ‘EU’ or ‘Community’ used in this document cover the EEA States. The European Economic Area is
composed of Iceland, Liechtenstein, Norway and the EU Member States.
1.1 General structure of the guidance on information

requirements
1.1.1 Information requirements in general

The information requirements as described in the BPR, are two-tiered:
I. The core data set (CDS) is mandatory for all product-types. This information
always has to be submitted, unless the rules for adaptation of standard
information are applicable (see below),
II. The additional data set (ADS) might be required to perform the risk assessment
under the following conditions (To Note: ADS is not applicable for Efficacy data
requirements):
a. ADS information on physical chemical properties, methods of detection
and identification and on the toxicological profile is required depending on
the intrinsic properties of the active substance or the biocidal product,
b. ADS information on the ecotoxicological properties and the environmental
fate and behaviour of the active substance or biocidal product is required
depending on the product-type, i.e. the foreseen use and route of
exposure,
c. ADS information on the ecotoxicological properties and the environmental
fate and behaviour might be required to refine the initial risk assessment.
1.1.2 Comparison of BPD-BPR

Figure 2 represents a comparison of the structure of the data requirements or
information requirements, respectively, under the BPD and under the BPR.
In the BPD legal text as well as in the TNsG on data requirements (EU, 2008a), CDS and
ADS are listed in separate Annexes. In contrast, the BPR text lists both CDS and ADS in
the same Annexes, but includes an additional column to indicate if the requirement is
ADS (see below). In addition, 'specific rules for adaptation from standard information
concerning some of the information requirements that may require recourse to testing of
vertebrates' represent data waiving possibilities and are listed alongside the respective
endpoints in Annexes II and III in the BPR.
BPD
Annex II Annex III

CDS ADS
II A II B III A III B
Active Substance Product Active Substance Product
BPR
Annex II Annex III

Active Substance Product
CDS and ADS CDS and ADS
Specific rules for adaptation from Specific rules for adaptation from
standard information standard information
Figure 2: Structure of data/information requirements under the BPD and the

BPR.
Unlike the BPD, the information requirements in Annexes II and III of the BPR are listed
in three columns:
 column 1 contains the actual requirements,
 column 2 indicates whether it is a CDS or an ADS,
 column 3 contains waiving statements when applicable (see Table 1). General
rules for data waiving can be found in Annex IV of the BPR.
Table 3 Three-column- structure of BPR information requirements in Annexes II

and III of the BPR.
COLUMN 1 COLUMN 2 COLUMN 3
Specific rules for adaptation

from standard information
ADS label or no label concerning some of the
Information requirement
(for CDS) information requirements that
may require recourse to testing
of vertebrates.
1.1.3 Volume II Part A: Document structure

This document (Volume II, Part A) includes general information on information
requirements (i.e. applicable to all four volumes) and covers the specific information
requirements for efficacy.
There are 3 sections:
Section 1 contains general guiding principles for information requirements which apply
(in general) to all four Volumes.
Section 2 covers CDS information requirements as listed in Title 1 of Annex II, point 6
“Effectiveness against Target Organisms” and point 7 Intended Uses and Exposure (of
the BPR). The section explains the BPR requirements for active substances (chemical
substances) and contains references to relevant test methods and further guidance. For
example, it offers guidance on which test is the most suitable for specific cases. In
addition, the section contains the specific rules for adaptation from standard information,
where applicable. These waiving rules are generally accepted, scientifically or technically
justified exemptions to the information requirements.
Section 3 provides CDS information requirements as listed in Title 1 of Annex III, point
6 “Effectiveness against Target Organisms” ” and point 7 Intended Uses and Exposure
(of the BPR). The section explains the BPR requirements for biocidal products (chemical
products) and contains references to relevant test methods and further guidance. Similar
to Section 2, it also contains references to relevant test methods and explains the Annex
III requirements. It also lists the specific rules for adaptation from standard information.
1.2 Guiding principles with regard to information requirements

in general
The following guiding principles reflect the general guidance on information requirements
which apply to all four volumes, as provided in the BPR.
1. The common core data set (CDS) forms the basis of the requirements. In
general, it is regarded to be a minimum set required for all substances and
product-types.
2. The additional data set (ADS) includes supplementary information
requirements. These are indicated in column 2 in the BPR Annexes. This
information may be required depending on the characteristics of the active
substance and/or the product-type and on the expected exposure of humans,
animals and the environment. The product’s use or application method needs to
be taken into account under both the proposed normal use and a possible realistic
worst case situation (Article 19(2) of the BPR).
3. The adaptation of information requirements outlined throughout this
Guidance is possible in certain cases for both CDS and ADS. For example, some
of the toxicological information requirements may be adapted occasionally when
the exposure is limited or when other product-type-specific factors apply; or for
the efficacy for new products with uses, mode of action or application technique
that is not covered by the guidance, other efficacy tests than stated in the
requirements can be more suitable. Sufficient and acceptable justification needs
to be provided for the adaptation. In addition, the inherent physical and chemical
properties of the substance or the product may justify waiving of some
information requirements. The guidance on General Rules for the Adaptation of
the Data Requirements is under development by the Commission and will be
made available accordingly. Until then please refer to Chapter 1 Section 1.4 of
the TNsG on Data Requirements (EU, 2008a). REACH, Guidance on QSARs and
grouping of chemicals could also be useful Guidance on information
requirements and chemical safety assessment Chapter R.6: QSARs and grouping
of chemicals.
4. The information requirements have been specified in as much detail as possible.
However, in certain cases, expert judgement by the applicant and by the
competent authority (CA) may be necessary in order to assess, for instance,
whether an additional study is needed or on which organism or under which
conditions a test should be performed. The applicant should propose the initial
expert judgement, which is then examined during the evaluation. In making the
decision as to whether additional testing is justified, the benefit for the risk
assessment (including intended use), the compatibility with accepted risk
assessment rationales, and the feasibility of the required tests may have to be
considered. When providing an expert judgement one must, when relevant, take
into account both the proposed normal use and a possible realistic worst case
situation. Expert judgement decisions should be scientifically justified and
transparent. In certain cases, the final decision on information requirements is
made by the Biocidal Products Committee (BPC). Special attention is required in
cases where there are endpoints of concern and clearly defined or standardised
methods are lacking. Here, the applicant is obliged to investigate if relevant
methods are applicable. New test methods are continuously being developed and
it is the applicant's duty to be up-to-date with the state of science regarding test
methods.
5. It is always the applicant who is responsible for the submission of the data. All
data provided in the application must always be supported by study reports,
other data or a letter of access. The information submitted by the applicant on
both active substances and biocidal products, and also on substances of concern
present in the biocidal product must be sufficient for conducting a risk
assessment and an efficacy assessment, and decision-making both at EU level
and on the level of the individual Member States. The applicant should consult a
CA as to which data should be submitted. This will allow for proper risk mitigation
measures to be decided upon if an active substance is likely to fail the criteria for
entry into the Union list of approved active substances or if a product is likely to
fail the criteria to be authorised at national or EU level.
6. The data submitted by the applicant will form the basis for classification and
labelling according to the CLP Regulation (harmonised classification in case of
active substances and self-classification in case of biocidal products). The active
substances may be subject to harmonised classification for the first time or the
data can be used to review a previous harmonised classification.
7. The data and test requirements should suit the individual circumstances and thus
make it possible to assess the risks and efficacy under a range of conditions. The
following parameters should be taken into account when preparing the application
for authorisation:
a. The characteristics of the application technique,
b. The user type (e.g. professional or non-professional users), and
c. The environment, in which the product is intended to be used or into
which the product may be released.
8. Article 62 (1) of the BPR states that In order to avoid animal testing, testing on
vertebrate animals for the purposes of this Regulation shall be undertaken only
as a last resort. Testing on vertebrate animals shall not be repeated for the
purposes of this Regulation. Concerning the latter, further detailed rules are
provided in Article 62 (2) of the BPR. The data generated and collected under
other legislative regimes, especially under Council Regulation (EU) No 544/2011,
Council Regulation (EC) No 1907/2006 and Council Regulation (EC) No

1272/2008 should be used, taking into account the rules on data protection.
Sharing of vertebrate data submitted under the BPD or BPR is mandatory.
9. With regard to data sharing, for guidance see the ECHA Biocides Guidance
webpages and the reference to the REACH Guidance on data sharing established
by ECHA (in accordance with Regulation 1907/2006 (REACH) and the Explanatory
Note clarifying which chapters are of relevance to the applicants under Biocidal
Products Regulation (EU) No528/2012 (BPR),
[http://echa.europa.eu/web/guest/guidance-documents/guidance-on-biocides-
legislation].
10. For renewal of a product authorisation the applicant must submit all relevant
data required under Article 20 of the BPR, that it has generated since the
initial authorisation. This requirement corresponds to the obligation to submit
any new data after the authorisation has been granted (Article 13(2) of the BPR).
This only applies to data that were generated by the applicant and not any other
data that may be available. For example, if several reports on similar studies are
available to the applicant they should all be submitted to allow a more sound risk
assessment with, among others, assessment of inter-species variability. An
exception to this rule, is for resistance when all available data including a
literature search, should be provided. The additional data should be of an
acceptable quality (see Annex IV, point 1 of the BPR).
11. Point 8 (a) of Annex VI to the BPR states that for the evaluation of a biocidal
product, the evaluating CA shall take into consideration other relevant technical
or scientific information which is reasonably available to them with regard to the
properties of the biocidal product, its components, metabolites, or residues. This
means that Member States and other stakeholders should also submit relevant
data to the evaluating CA, which is reasonably available to them but which has
not been available to the applicant. The applicant is not responsible for this
additional information. The applicant, however, is responsible to search for data
from all sources which he or she may reasonably be expected to have access to.
12. Public literature data can be used in the assessment if the following conditions are
fulfilled:
a. The data comply with the BPR Annex II, III introduction points 5-9.
b. The identity, purity and the impurities of the substance have to be defined
in the publication and to be comparable with the substance addressed in
the application.
c. The reporting of the study allows evaluation of the quality of the study.
If conditions a-c are met the applicant can claim that adequate data is publicly
available. Providing that the quality of public data fulfils the criteria, it can be
used as key studies.
13. There must be at least one key study or an accepted waiving justification for each
CDS endpoint given in the BPR Annexes II and III (and for each PT if more than
one PT is applied for). The same applies to ADS endpoints in the BPR Annexes II
and III, depending on the product-type (in the case of ecotoxicology endpoints
and environmental fate and behaviour) and on intrinsic physical-chemical or
toxicological properties of the substance or the product, respectively. A key study
is the critical study for a certain endpoint and has to be reliable and adequate to
use for the risk assessment and efficacy assessment. For criteria on the selection
of key studies and further information, see Parts B+C of each Volume for Efficacy,
Human Health and Environment. A study with a reliability indicator of 3 or 4

cannot be a key study and can be used only as supportive information.
14. When more than one adequate study is available, expert judgement should be
used to decide whether mean or median values should be used instead of the
result of a single key study. If there is divergent data from acceptable studies, a
study summary should be provided for all these studies. The study summary of
each study must be presented in the IUCLID file.
15. It is always possible to require additional information or studies if this is
considered to be necessary for a proper risk assessment, efficacy assessment and
decision making. The need for additional studies may be justified either by e.g.
the properties of the chemical (i.e. hazard) or by the predicted exposure. In
Article 8(2) of the BPR it states that where it appears that additional information
is necessary to carry out the evaluation, the evaluating competent authority shall
ask the applicant to submit such information within a specified time limit, and
shall inform the Agency accordingly. In that case, the stop-the-clock rule is
applied. Data may also be required for a substance of concern present in the
biocidal product other than the active substance. Similarly for a co-formulant 3to
demonstrate that it cannot be considered an active substance. However, the
detailed requirements are left mainly to be judged on a case-by-case basis and if
the outcome of the applicant’s assessment indicates a need for more data, the
applicant should already consider further studies.
16. Point 11 of Annex VI to the BPR states that During the process of evaluation,
applicants and the evaluating bodies shall cooperate in order to resolve quickly
any questions on the data requirements, to identify at an early stage any
additional studies required, to amend any proposed conditions for the use of the
biocidal product, or to modify its nature or its composition in order to ensure full
compliance with the requirements of Article 19 and of this Annex. The
administrative burden, especially for SMEs, shall be kept to the minimum
necessary without prejudicing the level of protection afforded to humans, animals
and the environment. BPR Specifically SMEs should be allowed extensive
guidance from the competent authorities in order to be able to fulfil the
obligations laid down in the BPR.
17. For the approval of the active substance a specification of the active substance
will need to be derived. This specification must be representative for the
manufacturing process as well as for the (eco)toxicological batches tested or, in
other words, the reference source would be the source for which the
(eco)toxicological data submitted cover the specification. Therefore it needs to be
ensured that all impurities in the proposed specification are considered in the
environmental fate and (eco)toxicological studies (batches used for the
environmental fate and (eco)toxicological studies may contain impurities at levels
equal or higher than the proposed specifications or it can be justified why some
impurities in the proposed specification are not covered by these studies).
1.3 On the use of additional Guidance documents
1.3.1 Existing biocides Guidance and other relevant documents

Part A for each of the four Volumes of the BPR Guidance replaces the TNsG on Data
Requirements in support of the BPD (EU, 2008a).
3
For more information see Technical Agreement for Biocides [https://echa.europa.eu/about-
us/who-we-are/biocidal-products-committee/working-groups]
In addition to the BPR guidance, Biocidal Products Directive (BPD) guidance and other
related documents are still considered applicable for new submissions under the BPR in
the areas where the BPR guidance is under preparation. Furthermore these documents
are still valid in relation to the applications for active substances for Annex I inclusion or
applications for product authorisation under the BPD that may still be under
evaluation. Also the Commission may have addressed some of the obligations in further
detail in the Biocides competent authorities meetings documents which applicants are
advised to consult. These document are available via a “related link” on the ECHA BPR
webpage [https://echa.europa.eu/guidance-documents/guidance-on-biocides-legislation]
This BPD Guidance and relevant documents should be utilised notwithstanding the
references to the BPD and without prejudice to the scientific content. The BPD Guidance
and related documents consist of:
 Emission Scenario Documents (ESD) which represent the main guidance to
estimate the amount of substances released into the environment,
 Technical Guidance Document (TGD) which forms the basis for the exposure- and
risk assessment of both active substances and products,
 Technical Notes for Guidance (TNsG) which deal specifically with biocides and BPD
implementation,
 The Manual of Technical Agreements (MOTA) which contains decisions from
Biocides Technical Meetings on the technical aspects of the risk assessment (EU,
2011a). The MOTA represents a living document, which is constantly updated.
Comments from the MOTA are included in this Guidance where considered
appropriate,
 Technical Agreements for Biocides (TAB) which provides the agreements of the
Working Groups of the Biocidal Products Committee (WGs) in a concise format,
 EU Evaluation Manual for the Authorisation of Biocidal Products (EU, 2012a).
1.3.2 REACH Guidance

In addition, REACH Guidance represents a major guidance source. The REACH Guidance
should be taken into account for the evaluation of biocides, where relevant and
indicated. The use of REACH Guidance is recommended for a number of endpoints with
the intention of facilitating a harmonised approach. ECHA Guidance can be obtained from
the ECHA website: https://echa.europa.eu/guidance-documents/guidance-on-reach.
1.3.3 CLP Guidance

In addition, the Guidance on the Application of the CLP Criteria (ECHA) represents an
additional guidance source. This guidance document is a comprehensive technical and
scientific document on the application of the CLP Regulation. ECHA Guidance can be
obtained from the ECHA website: https://echa.europa.eu/guidance-
documents/guidance-on-clp.
1.4 General guidance on generating new information

If new tests are performed in order to fulfil the data requirements, the following
principles have to be followed:
According to point 5 (Methods of Detection) of Annex II and Annex III of the BPR, as a
general principle, tests shall be conducted according to the methods described in
Commission Regulation (EC) No 440/2008. These methods (“EC methods”) are based on
methods recognised and recommended by international bodies, in particular OECD. In
the event of a method being inappropriate or not described, other methods shall be used
which are scientifically appropriate. Their use needs to be justified. Recommended test
methods are listed in the endpoint sections.
According to point 6 (Effectiveness against Target Organisms) of BPR Annexes II and III,
tests 'should comply with the relevant requirements of protection of laboratory animals,
set out in Directive 2010/63/EU'.
Furthermore, point 6 of BPR Annexes II and III explains that 'Tests performed should
comply with… in the case of ecotoxicological and toxicological tests, good laboratory
practice…. or other international standards recognised as being equivalent by the
Commission or the Agency.' At the moment there are no “other international standards”
considered equivalent to GLP. Ideally, tests are carried out in accordance with Good
Laboratory Practice (GLP) or similar quality assurance systems (ISO), although this is
not mandatory for efficacy tests.
In addition, point 6 of BPR Annexes II and III declares that 'Tests on physico-chemical
properties and safety-relevant substance data should be performed at least according to
international standards.') The test methods for the physico-chemical properties are
described in the Test Methods Regulation (EC No 440/2008), whereas preferred tests for
the purposes of physical hazard classification are referred to in Part 2 of Annex I to CLP
Regulation, via references to the UN Recommendations on the Transport and Dangerous
Goods, Manual of Test and Criteria, UN-MTC (UN, 2009). The testing according to
international standards should be interpreted as testing carried out by laboratories
complying with a relevant recognised standard (e.g. ISO/IEC 17025, ISO 9001).
However, most of the methods listed in the Test Methods Regulation 'are developed
within the framework of the OECD programme for Testing Guidelines, and should be
performed in conformity with the principles of Good Laboratory Practice, in order to
ensure as wide as possible ‘mutual acceptance of data’. From 1 January 2014, new tests
for physical hazards must be carried out in compliance with a relevant recognised quality
system or by laboratories complying with a relevant recognised standard as stipulated by
Article 8(5) of the CLP Regulation. Where relevant recognised standards for testing are
applicable, the use of the most recent updates is advised, for example the EN and ISO
standards.
Where test data exist that have been generated before the DoA of the BPR by methods
other than those laid down in the Test Methods Regulation, the adequacy of such data
for the purposes of the BPR and the need to conduct new tests according to the Test
Methods Regulation must be decided on a case-by-case basis. Amongst other factors,
the need to minimise testing on vertebrate animals needs to be taken into account
(Article 90(2) of the BPR). Such a decision should first be proposed by the applicant
when collecting data for the application and then evaluated by the competent authority
when checking the completeness of the application and approving the justification
provided for such a case. If a test has been performed, that does not comply with the
Test Methods Regulation, the nature of the differences must be indicated and justified.
The same applies to deviations from the test protocol used. The test protocol should be
provided in full unless there is sufficient detail in the test report.
In certain cases, testing can be replaced by modelling using (Q)SAR, Quantitative
Structure Activity Relation. Guidance on information requirements and chemical safety
assessment Chapter R.6: QSARs and grouping of chemicals..
As a general rule, tests on the active substance should be performed with the substance
as manufactured. For some of the physical and chemical properties' tests, a purified form
of the substance is being tested, which is indicated by footnote 2 in Annex II column 1 of
the BPR, in other cases, the applicant is free to choose between testing on either purified
form or the form as manufactured as indicated by footnote 1 in Annex II column 1 of the
BPR. The “Active substance as manufactured” is the active substance in its natural state
or as obtained by a production process. This includes any additive necessary to preserve

the stability of the products and any impurity deriving from the process used. It
excludes, however, any solvent which may be separated without affecting the stability of
the substance or changing its composition. Furthermore, the identity, purity and the
impurities of the substance have to be defined and to be comparable with the substance
subject to the application.
In order to implement the three R’s, Replacement, Refinement and Reduction of animals
in research, the following should be taken into account when planning new tests: If there
is an established EC test method or OECD test guideline for a given purpose, for example
testing of acute oral toxicity, and in addition one or more alternative methods which may
equivalently be used, the test method that requires a lower number of test animals
and/or causes less pain should be used. A number of alternative tests either not using
test animals or reducing the number of test animals are under development and when
endorsed, these tests are preferred when new tests have to be performed.
A substance which is approved as an active substance (included in the Union list of
approved active substances) should be related to the active compound in the
formulation. This means that a case-by-case decision must be taken by the evaluating
CA on the name to be given to the active substance. This could be for example simple
ions or different molecular structures, precursor/activator, or unstable/breakdown active
components, or multiple component products. The specifications of the used material
need to be described in detail (point 7 of Annex II to the BPR) i.e. a brief description of
the composition for all batches used in tests is needed. Where testing is done using an
active substance the material used should be of the same specification as that which
would be used in the manufacture of preparations to be authorised except where radio
labelled material is used. All batches of a substance or a product used for testing should
be representative of typical commercial material for which the approval is applied for and
within the production concentration range. If for any test the composition of the
substance or product is different from that quoted for commercial material, full details
must be provided. Certain exceptions on this general rule are provided in the Guidance.
When the long term stability is in doubt, the composition should be determined before
testing. Where appropriate, details of the stability of the substance in any vehicle used
during testing should also be specified. For certain tests (e.g. some physico-chemical
tests) there are specific requirements for purity of the active substance.
In addition, the specific guidance provided in the relevant test guidelines should always
be followed. For instance, guidance on when the testing of transformation products
instead of the active substance is relevant may be found in the test guidelines
concerned.
Some active substances may have characteristics that impede testing or limit the
methods that can be used. Substances, which are difficult to test, need special attention
(OECD, 2000a). The difficulties may arise from the chemical nature of the substance
(e.g. insoluble substances, metals, complex mixtures of chemicals, oxidising substances
or surface active compounds (surfactants)). Further difficulties may be owing to the
activity of the substance.
Where studies are conducted using an active substance produced in the laboratory or in
a pilot plant production system, the studies must be repeated using the active substance
as manufactured unless it can be justified that the test material used for the purposes of
testing and assessment is technically equivalent. In cases of uncertainty, appropriate
bridging studies must be submitted to serve as a basis for a decision on the possible
need to repeat studies. The test guidelines usually include guidance on the limitations of
the method or give detailed guidance on how the method should be modified when
testing chemicals with specific characteristics. Separate Guidance documents may be
available for specific testing situations. For instance, Guidance on intermediate
compounds has been published Guidance on intermediates. The Guidance provided in

the Technical Guidance Document concerning risk assessment of new and existing
substances Part II (EU, 2003) should also be followed when designing the testing
strategy for substances that are difficult to test.
The test results must be reported properly and according to the guidelines used. The
study summaries and full study reports of all key studies should be included in the data
forwarded to the CA. Relevant analytical raw data should be provided on request. For
example, individual data points should be provided in addition to mean values and
calibration equations should be provided to allow a suitable evaluation of the study by an
assessor.
1.5 Guidance on non-submission of information

The guidance text to be provided in this section is under development by the
Commission and will be made available accordingly. Until then please refer to Chapter 1
Section 1.4 of the TNsG on Data Requirements (EU, 2008a).
1.6 Testing of metabolites and transformation products

For the efficacy aspects of metabolites or transformation products, they are included in
the test relevant for the use of the active substance and the biocidal product. Metabolites
or transformation products should not be tested separately for efficacy.
For the toxicology aspects of metabolites and transformation products, the possibility of
the formation of metabolites not investigated by the usual testing must be taken into
account. See section on metabolism studies in mammals in Volume III .
For environmental aspects, metabolites relevant for the risk assessment can be
distinguished as:
 Major metabolite:
 formed in amounts of ≥ 10% of the active substance at any time of the
degradation studies under consideration, or
 the metabolite appears at two consecutive sampling points at amounts ≥ 5%,
or
 at the end of the study the maximum of formation is not yet reached but
accounts for ≥ 5% of the active substance at the final time point;
 Minor metabolite: all metabolites not meeting the above criteria;
 Ecotoxicologically relevant metabolite: any minor or major metabolite which e.g.
poses a comparable or higher hazard than the active substance.
In general, an environmental risk assessment for the relevant compartments needs to be
performed for all major metabolites. However, as a first step a semi-quantitative
assessment of these metabolites using the available data and expert judgement to fill
data gaps may be sufficient. A quantitative assessment should be performed on a case-
by-case basis.
If there is any reason for concern, a risk assessment also needs to be performed for
those ecotoxicologically relevant metabolites which are minor metabolites.
1.7 Background documents

Legal texts
For the detailed legal texts (plus amendments and annexes, when applicable) cited in
this guidance document and listed below in this section, please visit the eur-lex
bibliographic website: http://eur-lex.europa.eu. or ECHA website:

http://echa.europa.eu/regulations/biocidal-products-regulation/legislation
Regulations
Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18
December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of
Chemicals (REACH), establishing a European Chemicals Agency, amending Directive
1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission
Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission
Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC; (REACH)
Council Regulation (EC) No 440/2008 of 30 May 2008 laying down test methods
pursuant to Regulation (EC) No 1907/2006 of the European Parliament and of the
Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals
(REACH); (Test Methods Regulation)
December 2008 on classification, labelling and packaging of substances and mixtures,
amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending
Regulation (EC) No 1907/2006; (CLP Regulation).
October 2009 concerning the placing of plant protection products on the market and
repealing Council Directives 79/117/EEC and 91/414/EEC; (PPPR).
Commission Regulation (EU) No 1152/2010 of 8 December 2010 amending, for the
purpose of its adaptation to technical progress, Regulation (EC) No 440/2008 laying
down test methods pursuant to Regulation (EC) No 1907/2006 of the European
Parliament and of the Council on the Registration, Evaluation, Authorisation and
Restriction of Chemicals (REACH).
Commission Regulation (EU) No 10/2011 of 14 January 2011 on plastic materials and
articles intended to come into contact with food.
Commission Regulation (EU) No 544/2011 of 10 June 2011 implementing Regulation
(EC) No 1107/2009 of the European Parliament and of the Council as regards the data
requirements for active substances.
Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May
2012 concerning the making available on the market and use of biocidal products;
(BPR).
Commission Regulation (EU) No 487/2013 of 8 May 2013 amending, for the purposes of
its adaptation to technical and scientific progress, Regulation (EC) No 1272/2008 of the
European Parliament and of the Council on classification, labelling and packaging of
substances and mixtures.
Directives
Council Directive 75/440/EEC of 16 June 1975 concerning the quality required of surface
water intended for the abstraction of drinking water in the Member States.
Council Directive 80/68/EEC of 17 December 1979 on the protection of groundwater
against pollution caused by certain dangerous substances.
Council Directive 88/379/EEC of 7 June 1988 on the approximation of the laws,
regulations and administrative provisions of the Member States relating to the
classification, packaging and labelling of dangerous preparations.
Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998
concerning the placing of biocidal products on the market; (BPD).
Council Directive 98/83/EC of 3 November 1998 on the quality of water intended for
human consumption; (The Drinking Water Directive (DWD)). Consolidated version 2009-
08-07.
Directive 2000/60/EC of the European Parliament and of the Council of 23 October 2000
establishing a framework for Community action in the field of water policy; (The EU
Water Framework Directive, WFD). Consolidated version 2009-06-25.
on the inspection and verification of good laboratory practice; (GLP).
on the harmonisation of laws, regulations and administrative provisions relating to the
application of the principles of good laboratory practice and the verification of their
applications for tests on chemical substances; (GLP).
Directive 2006/118/EC of the European Parliament and of the Council of 12 December
2006 on the protection of groundwater against pollution and deterioration; The
Groundwater Directive.
Directive 2008/105/EC of the European Parliament and of the Council of 16 December
2008 on environmental quality standards in the field of water policy, amending and
subsequently repealing Council Directives 82/176/EEC, 83/513/EEC, 84/156/EEC,
84/491/EEC, 86/280/EEC and amending Directive 2000/60/EC of the European
Parliament and of the Council; The Priority Substances Directive.
Directive 2010/63/EU of the European Parliament and of the Council of 22 September
2010 on the protection of animals used for scientific purposes.
Decisions
2000/532/EC: Commission Decision of 3 May 2000 replacing Decision 94/3/EC
establishing a list of wastes pursuant to Article 1(a) of Council Directive 75/442/EEC on
waste and Council Decision 94/904/EC establishing a list of hazardous waste pursuant to
Article 1(4) of Council Directive 91/689/EEC on hazardous waste.
1.8 Sources of test methods and standards

AFNOR Standards can be purchased from the website of AFNOR, the French Institute for
Standardisation (http://www.afnor.org/en/).
ASTM Standards may be obtained from the American Society of Testing Methods, West
Conshohocken, Pennsylvania, USA (http://www.astm.org).
BSI Standards can be purchased from the website of BSI, the English Institute for
Standardisation (https://www.bsigroup.com/#).
CEB Methods can be purchased from the website of AFPP, the French Association for
plant protection (http://www.afpp.net/).
CIPAC methods may be purchased from the Collaborative International Pesticides
Analytical Council (http://www.cipac.org).
DIN Standards can be purchased from the website of DIN, the German Institute for
Standardisation (http://www.din.de).
DVG Standards can be purchased from the website of DVG, the German Veterinary
Medical Society (http://www.desinfektion-dvg.de).
EC methods are published in the Official Journal of the European Union. The testing
methods are described in the Test Methods Regulation (Regulation (EC) No 440/2008).
They are regularly updated with new methods introduced as required..
EPPO Guidelines may be obtained from the Secretary of the European and Mediterranean
Plant Protection Organisation (EPPO), Paris, France (http://www.eppo.int/).
European Standards (CEN standards), transposed as national standards, can be
purchased from National Members and Affiliates of the European Committee for
Standardisation (CEN). Contact information for CEN National Members and also draft
European Standards may be obtained from the CEN Central Secretariat, Brussels,
Belgium (http://www.cen.eu).
ISO International Standards: orders should be addressed to the ISO member bodies
(non-USA users, if subscribing to Internet from a USA-based provider, should consult the
ISO member list for ordering ISO standards in their country) which are normally the
primary ISO sales agents, or for customers in countries where there is no member body,
to the ISO Central Secretariat, Geneva, Switzerland (http://www.iso.org/iso/store.htm).
OECD test methods can be obtained directly via their internet address
(http://www.oecd-ilibrary.org/environment/oecd-guidelines-for-the-testing-of-
chemicals_chem_guide_pkg-en).
US EPA Office of Prevention, Pesticides, and Toxic Substances Test Guidelines can be
obtained from the EPA website
(http://www.epa.gov/ocspp/pubs/frs/home/testmeth.htm).
VAH Standards can be purchases from the website of VAH, the German Association for
Applied Hygiene (http://www.mhp-verlag.de/en/home)
VDI Guidelines can be obtained from the website of VDI, The Association of German
Engineers (http://www.vdi.de).
WHO guidelines for efficacy testing can be obtained from WHO website
(http://www.who.int/whopes/guidelines/en/).
Guidance on the BPR: Volume II. Part A
2 Part A: Dossier Requirements for Active Substances
BPR Annex II, Title 1, 6 Effectiveness against target organisms

NOTE to the reader:
The following section headings include a reference to the relevant section/point in
the BPR Annex for ease of cross reference.
2.1 Point 6 Effectiveness against target organisms

Efficacy data are a fundamental component in the regulatory management and decision
making process for active substances. Efficacy data are required to establish the benefit
arising from the use of the active substance in biocidal products and must be balanced
against the risks their use poses to man and the environment.
Approval of an active substance will only be granted according to Art. 4 (1) of the BPR if
a representative biocidal product containing the active substance fulfils the minimum
requirements in the active substance part of Volume II Parts B+C. Thus, the data
provided must show the efficacy of an active substance used in biocidal products or,
where such claims are made, in treated articles. The information given according to BPR
Annex II point 6 on the effectiveness and intended uses of the active substance must be
sufficient to permit an evaluation of the representative biocidal product. It is particularly
important that efficacy tests on a representative product reflect the use conditions given
for the active substance. When active substances are used in treated articles, use
conditions often differ widely. In this case it can be meaningful to reflect different use-
conditions by submitting different efficacy tests with the example product. Furthermore,
efficacy studies must establish that the concentration of the active substance used for
the risk assessment is a relevant and efficacious concentration for the use(s) intended.
The efficacy studies with the representative biocidal product should generally be carried
out in accordance with section 3.1 (of this guidance). If the information requirements
differ for active substance approval, this is indicated below.
The information must include, for every product type separately.
2.1.1 Point 6.1 Function, e.g. fungicide, rodenticide, insecticide,

bactericide and mode of control e.g. attracting, killing, inhibiting
Please follow guidance in Section 3.1.1.
2.1.2 Point 6.2 Representative organism(s) to be controlled and

products, organisms or objects to be protected
2.1.3 Point 6.3 Effects on representative target organism(s)

Please follow guidance in Section 3.1.3
2.1.4 Point 6.4 Likely concentration at which the active substance will
be used in products and, where appropriate, in treated articles
2.1.5 Point 6.5 Mode of action (including time delay)

2.1.6 Point 6.6 Efficacy data to support these claims on biocidal

products and, were label claims are made, on treated articles
Point 6.6 of Annex II to the BPR refers to “ (…) any available standard protocols,
laboratory tests or field trials used including performance standards where appropriate”.
During the review of an active substance at the active substance approval stage, both
the efficacy of the active substance itself and of a representative biocidal product
containing that active substance are assessed.
Information, in the form of studies or justifications, must be provided to support the
requirements set out in sections 3.1.1 to 3.1.5 of this guidance.
The information for the submission of efficacy data given in sections 3.1.6 and 3.1.7 of
this guidance is also relevant for active substance approval. Please note: the SPC
mentioned in section 3.1.6 is not relevant for active substance approval. Please provide
the information in IUCLID instead.
2.1.6.1 Efficacy of the active substance
During the active substance approval stage, the efficacy of the active substance itself
must be demonstrated.
This is normally done by carrying out testing using the technical active substance, or a
simple dilution of the active substance in water or an appropriate matrix. The testing is
carried out without other substances present which may affect the efficacy.
The efficacy studies submitted on the active substance should be capable of
demonstrating the innate activity of the active substance against representatives of the
proposed target organisms at the concentration relevant for the risk assessment.
For that purpose, innate activity of an active substance could be defined as the capacity
of an active substance to provide an effect on one or more target organisms relevant to
the use being considered.
Generally, efficacy data are generated from laboratory tests, are performed by the
applicant. Nevertheless, efficacy data from literature could also be acceptable if the
application rate, target organisms, area of use and the identity of the active substance is
described and are relevant (for general requirements to be fulfilled by literature see
point 12 in section 1.2 of the BPR Guidance Volume I, Part A: Information
Requirements). For example, if cited literature is used to support a preserving effect it
must also show that untreated test specimens supported growth. When curative effects
are claimed the cited literature must demonstrate the efficacy of the active substance
according to the requirements per PT. The use of cited literature should be agreed
between the applicant and the evaluating CA (eCA) on a case by case basis.
If no efficacy tests with the active substance itself are available, tests carried out with a
formulated product may be acceptable where a suitable justification is provided by the
applicant addressing the possible influence of co-formulants on the efficacy. If the co-
formulants used potentially have biocidal activity, it is essential to demonstrate that the
efficacy is due to the active substance and not to the co-formulants, e.g. a test should
be performed with all co-formulants but without the active substance.
2.1.6.2 Efficacy of the representative biocidal product at the active substance
approval stage
Although approval for the Union list is primarily concerned with the active substance,
efficacy data is also required for a representative product to demonstrate that the active
substance is capable of producing an effect on the target organism when included in a
formulated product.
Ideally efficacy data on an existing biocidal product should be submitted. If this is not
possible, data on a “dummy product4” could be acceptable to demonstrate that the
active substance is capable of producing an effect on the target organism in a relevant
formulation.
As the intention of the evaluation is to demonstrate the efficacy of the active substance
in a formulation, it is important that testing, as far as possible, be carried out on a
formulation which only contains a single active substance.
Efficacy data packages for formulations containing two or more active substances are not
fully suitable for determining the activity contribution from the active substance under
evaluation. For that reason great attention should be paid to justify the contribution of
the active substance under evaluation to the total efficacy of the product. Information
about the mode of action/function of the other active substances present in the product
is also requested. For more details please refer to Volume II parts B+C, section 4.3.
The evaluation of the effectiveness of the representative product at the stage of active
substance approval is not as detailed as that carried out for product authorisation.
Nevertheless, the level of efficacy (e.g. the kind of activity “curative” or “preventive”)
have to be consistent with the uses claimed and fulfil the minimum requirements
mentioned in the active substance part (Guidance on the BPR: Volume II, Parts B+C).
2.1.6.3 Approval of the active substance
Where the innate activity of both the active substance and representative biocidal
product against the target organisms has been demonstrated, a recommendation can be
made for approval of the active substance.
Where the level of activity demonstrated for the representative biocidal product would
not normally be considered high enough for a product authorisation, the applicant should
justify why the levels of activity noted should be considered acceptable (e.g. where there
only is a dummy product containing only the active substance under consideration, or
where the active substance will always be used in combination with one or more other
active substances).
Where the applicant provides an acceptable justification, approval of the active
substance should still be recommended and the efficacy more fully addressed at the
product authorisation stage.
It is not necessary to demonstrate efficacy against all of the claimed target organisms at
the active substance approval stage. However, approval will only be granted for use
against those organisms for which efficacy has been demonstrated. Additional target
organisms may be added at product authorisation, but must be supported by suitable
efficacy data.
2.1.7 Point 6.7 Any known limitations on efficacy

Please follow guidance in section 3.1.8.
2.1.7.1 Point 6.7.1 Information on the occurrence or possible occurrence of

the development of resistance and appropriate management strategies
Please follow guidance in section 3.1.8.1.
4 A “dummy product” is a product that is not fully formulated. It is not intended to be placed on
the market. For more information please consult section 4.4 of the Guidance on the Biocidal
Products Regulation Volume II Efficacy - Assessment and Evaluation (Parts B+C)
2.1.7.2 Point 6.7.2 Observations on undesirable or unintended side-effects,

e.g. on beneficial and other non-target organisms
Please follow guidance in section 3.1.8.2.
2.2 Point 7 Intended uses and exposure
2.2.1 Point 7.1 Field of uses envisaged for biocidal products and, where
appropriate, treated articles
The intended and potential use should be indicated together with the fields of use. For
active substance evaluation at least one realistic use per PT should be given. Additional
uses may be identified and supported at product authorisation stage.
The information on the intended use should be in accordance with the uses presented in
section 2.1.1 of this guidance (BPR Point 6.1) and should be sufficient to allow an
approximate and realistic estimation of human and environmental exposure to the
product or treated article, respectively under conditions reflecting a representative use.
Additionally, it should be sufficient to allow an approximate and realistic estimation of
the efficacy of the active substance/biocidal product.
The uses intended should be relevant to the product type(s) under consideration.
Uses taking place outside the EU should be disregarded. Any operation carried out with a
view to exporting the biocidal product or the treated article outside the EU should also be
disregarded.
2.2.2 Point 7.2 Product-type(s)

The intended product-type(s) as listed in Annex V to the BPR should be indicated.
2.2.3 Point 7.3 Detailed description of the intended use pattern(s)

including in treated articles
Provide a detailed description of the overall use patterns linked to the fields of use
intended. Use means all operations carried out with a biocidal product, including storage,
handling, mixing and application.
The information on the intended use in accordance with BPR Point 6.1 (see section 2.1.1
of this guidance) should be sufficient to allow efficacy evaluation and an approximate but
realistic estimation of human and environmental exposure to the active substance under
realistic worst case conditions and for an evaluation of the use-conditions under which
the biocidal product is intended to be used.
The following product-type-specific guidance should be followed if applicable:
 For disinfectants state the area of use e.g. ‘surface disinfection in hospitals and
other health care institutions’, instead of only ‘surface disinfection’.
 For material preservatives information on the type of matrices should be given.
Furthermore information on ageing, weathering etc. which could limit efficacy
should be given.
 For material preservatives of product-types 6, 7, 9, and 10, the different
environments in which the material treated with the product is intended to be
used should be indicated (e.g. indoors or outdoors, in cattle sheds, preserved
material used in contact with drinking water or food storage).
 For product-type 8, the use classes, (as defined in the standard EN 335-1
Durability of wood and wood-based products. Definition of use classes - Part 1:
General), in which wood treated with the product is intended to be used should
be indicated for wood preservatives. For uses not described in this standard, such
as curative or antisapstain products, see also Volume II, Parts B+C: PT 8.
 For product-type 21, in addition to the fields of use, specify also if the product or
treated article, respectively, is intended to be used in marine environments, in
brackish water and/or in fresh waters. The uses should also distinguish between
for example, aqua-culture, buoys and other small static objects, sluice doors,
harbour constructions, oil rigs, inlet pipes of cooling water systems, marine
sensors, ships' hulls (e.g. deep sea, coastal, inland waterway vessels), etc.
 For treated articles, intended and/or potential uses which show a specific
exposure pattern or specific use-conditions should be listed, even if they belong
to the same product-type (e.g. use for antimicrobial treatment of underwear, use
for treatment of food containers, etc.). If necessary, the applicant should suggest
use-categories which include similar exposure patterns, and/or similar use-
conditions relevant for efficacy.
2.2.4 Point 7.4 Users, e.g. industrial, trained professional,

professional or general public (non-professional)
Indicate users with the help of the user categories5 :
 Industrial user: user involved in manufacturing, handling and/or packaging of
actives or products at industrial sites (e.g. handling of in-can preservatives);
 Trained professional: professional user using end-products outside industry in the
course of their professional activities and have extra-training or certification
process (e.g. handling of avicides and piscicides);
 Professional user: professional user using end-products outside industry, but in
the course of their professional activities (e.g. handling of preservatives in liquid-
cooling and processing systems);
 General public (non-professional user): member of the population or citizen that
make a private use of a biocidal product at a workplace or at home (consumer)
(e.g. handling of disinfectants for water beds or mosquito repellents).
Users outside the EU should be disregarded.
2.2.5 Point 7.5 Likely tonnage to be placed on the market per year
and, where relevant, for the intended major use categories
An estimate of the quantity of the active substance placed, or to be placed, on the EU
market by the applicant (i.e. imported or produced) per year. The quantities for biocidal
use and in which product-type(s) should be given, and where relevant for the intended
major use categories, within each product-type. The quantities for use other than as a
biocide should be indicated, if available. In case of the renewal of approved active
substances, tonnage data should cover the last three years. For new substances not
previously marketed, production plans covering three years after authorisation should be
provided.
5
See also for additional information the Note for guidance (CA-May16-Doc.5.4.a- Final) User
categories of anticoagulant rodenticides: common understanding and adaptation to national
situations in case of mutual recognition - /CircaBC/SANTE/BPR -
Public/Library/documents_finalised
2.2.6 Point 7.6 Exposure data in conformity with Annex VI to this

Regulation
The principles of the exposure assessment, as outlined in Annex VI to the BPR on the
common principles for the evaluation of dossiers for biocidal products points 32-34, and
45 should be taken into account when assessing the exposure associated with the uses
and disposal of an active substance. According to Annex VI, an exposure assessment
needs to be carried out for human and environmental populations for which exposure to
a biocidal product occurs or can reasonably be foreseen.
For further guidance on exposure assessment on active substances, see Parts B+C -
Evaluation and Assessment of Volumes III and IV of the BPR Guidance.
2.2.6.1 Point 7.6.1 Information on human exposure associated with the

intended uses and disposal of the active substance
The provided information should be sufficient to allow an approximate but realistic
estimation of human (occupational and consumer) exposure associated with the
proposed/expected uses and disposal of an active substance. The prediction of the
exposure levels should also describe a realistic worst case situation, excluding accidental
exposure and abuse. Exposure levels or concentrations need to be derived based on
available measured data and/or modelling.
2.2.6.2 Point 7.6.2 Information on environmental exposure associated

with the intended uses and disposal of the active substance
The provided information should be sufficient to allow an approximate but realistic
estimation of environmental exposure associated with the proposed/expected uses and
disposal of an active substance. The prediction of the exposure levels in all relevant
environmental compartments and respective biota should also describe a realistic worst
case situation, excluding accidental exposure and abuse. Exposure levels or
concentrations need to be derived based on available measured data and/or modelling.
2.2.6.3 Point 7.6.3 Information on exposure of food producing animals

and food and feeding stuffs associated with the intended uses of the
active substance
To estimate exposure of food producing animals follow the Guidance on Estimating
Livestock Exposure to Active Substances used in Biocidal Products (see Volume III Parts
B+C Section 6).

including leaching data (either laboratory studies or model data)
Articles treated with or incorporating biocidal products can lead to consumer and
environmental exposure if chemical constituents of the biocidal product are released in
any way from these types of articles. Exposure from treated articles during service life
may in some situations be the most significant exposure to the active substance (and to
substance(s) of concern in the case of product authorisation applications). Specifically,
articles consisting of different types of polymers can be used in a large range of
consumer applications, which makes the exposure situation very complex. The diversity
of applications has consequences both for the exposure of consumers and the
environment. For consumers, possible worst case exposure scenarios have to be defined.
Then, applications leading to simultaneous consumer exposure within a certain
timeframe have to be modelled. For the environment, emissions from uses with similar
exposure patterns (e.g. down the drain, direct exposure to soil, etc.) should be summed
up for the respective compartment. When treated articles are imported into the EU, the
only possible way to carry out a risk assessment is by active substance evaluation. It is
therefore important that the applicant for an active substance approval describes the
intended or potential uses in a way as detailed as possible so that the appropriate
exposure scenarios can be applied. Here it is noted that the applicant may not always
have this detailed knowledge, in particular with regards to treated articles imported into
the EU.
The applicant submitting an application for approval of an active substance (or for
authorisation of a biocidal product to treat an article) which is intended to be used in
biocidal products to treat an article must submit an exposure assessment. The
assessment can be based on model calculations with well supported default values
and/or measured laboratory leaching values, or based on the results of an exposure
study. For several product-types, information on leaching will be required as listed in
Volume IV Parts B+C (section 2) on product-type-specific data requirements on the
foreseeable route of entry into the environment based on the intended use.
It has to be decided on a case-by-case basis how detailed the exposure assessment has
to be: i.e. whether all intended uses in treated articles need to be covered or not. Here a
balance has to be found between the ability of the applicant to obtain all the relevant
information to carry out a detailed exposure assessment, the requirements for the
approval process and the relevance of each use in relation to the foreseen exposure.
The need for additional data needs to be judged on a case-by-case basis. The REACH
Guidance on exposure assessment on treated articles (ECHA) is very comprehensive and
can be applied in many cases. The OECD Guideline document on how to write emission
scenarios for the life-cycle step service life (OECD, 2008a) can also be useful.
2.2.6.4.1 Environment
Depending on the use, either the tonnage approach or an approach in which leaching
rates are determined from the treated article is required for the calculations. If the
tonnage approach is not used, information on the likely application rate must be stated
for the most relevant uses and modes of application. Generally, a detailed quantitative
description of the fields of use intended should be given to allow for a realistic worst-
case estimation of environmental exposure of the active substance (or any substances of
concern for applications for product authorisation). When using the tonnage approach, it
may be necessary to allocate a certain percentage of the overall tonnage to certain uses
if such uses have a different exposure profile. Information on the estimated service life
time of the treated article and possible reapplications, if relevant, is required.
In general, a tiered approach should be followed for leaching rate determination:
 Tier 1: worst-case assumption where 100% of the active substance (and for
product authorisation applications – if present in the biocidal product – the
substance(s) of concern). The life time can be different and depends on the
product-type and use of the treated article.
 Tier 2: validated laboratory leaching test. The uncertainty of using a laboratory
test to predict environmental concentrations should be addressed by using an
assessment factor.
 Tier 3: semi-field tests or field studies. The duration of the field- or semi-field
study should reflect the exposure situation and enable an extrapolation to the
service life of the treated article.
The service life time of an article can be different and depends on the product-type and
use of the treated article. For polymers, default values for the life times of different
consumer articles are given in the OECD Emission scenario document on plastic additives
(OECD, 2009a). For wood preservatives, the service life time of treated timber is defined
by the mode of application and the use classes (OECD, 2009b). Guidance on
extrapolation of leaching rates for life time calculations can be found in the Emission
Scenario Document for product-type 8 (OECD, 2000b).
For polymers, it has to be taken into account that leaching rates can vary quite
significantly depending on the type of polymer (polyethylene leaches less than
polyamide), the type of application (incorporation or coating) and of the use (a regularly
washed textiles leaches much more than a kitchen worktop). This observation will apply
for many other types of treated articles. For wood preservatives, no reliable method
exists to predict the leaching rate based on physico-chemical properties and therefore
leaching studies are normally required.
For some product-types like e.g. PT 1, 2, 4, 7, 9, and 10, the biocidal product is often
added as a premix concentrate to a surface treatment system or a polymer. The surface
treatment system or the polymer may subsequently be applied to a surface and/or
incorporated into the matrix from which leaching of the active substance(s) (and possibly
substances of concern) will take place. As these surfaces/matrices may have many
different characteristics, it is important that the applicant submits data for the leaching
behaviour of different types of surfaces/matrices which are likely to cover the worst-case
leaching behaviour. The emissions during service life are considered to be diffuse
emissions that usually cause exposure on a wider scale compared to local emissions.
Possible environmental emissions from articles treated with the same active substance
and similar exposure patterns should be summed up. Uses within the same exposure
pattern can be summarised to simplify the aggregated exposure assessment.
Further Guidance:
 ECHA REACH Guidance on information requirements and chemical safety
assessment. Chapter R.17: Estimation of exposure from articles (ECHA);
 Guidance note on leaching rate estimations for substances used in biocidal
products in PT 07, 09 and 10 (EU, 2010b);
 Workshop on determination of the leaching rate from treated wood to the
environment (EU, 2005b);
 OECD Test Guideline 313 Estimation of Emissions from Preservative - Treated
Wood to the Environment;
 OECD Series on Testing and Assessment Number 107 Preservative- treated wood
to the environment: for wood held in storage after treatment and for wooden
commodities that are not covered and are not in contact with ground;
ENV/JM/MONO(2009)12 (OECD, 2009b);
 CEN/TS 15119-2 (2012): Durability of wood and wood-based products -
Determination of emissions from preservative treated wood to the environment -
Part 2: Wooden commodities exposed in Use Class 4 or 5 (in contact with the
ground, fresh water or sea water) - Laboratory method;
 CEN/TS 15119-1 (2008): Durability of wood and wood-based products -
Determination of emissions from preservative treated wood to the environment -
Part 1: Wood held in the storage yard after treatment and wooden commodities
exposed in Use Class 3 (not covered, not in contact with the ground) - Laboratory
method.
2.2.6.4.2 Human Health
In a tier 1 exposure estimation, the chemical composition of the article is used to assess
whether the total amount of the active substance (or substances of concern in case of
product authorisation applications) present in the article may exceed the AEL or
reference value. In a tier 2 assessment, exposure estimations may be refined by data
obtained in e.g. leaching tests. Such tests must be conducted in appropriate media (for
example, artificial sweat, saliva, etc.). They should also be specific for the intended
material (for example type of polymer), use situation (for example mouthing, wearing on
the skin), consistency of the article (for example, hard, smooth or porous) and duration
of exposure. It is also important to obtain leaching rates during the service life of an
article because in many cases articles give a high level of exposure during the first
period of use and a lower level of exposure after repeated uses.
A special case of treated articles are food contact materials, which must also undergo a
dietary risk assessment (see data requirements in Annex II 8.16 and Annex III 8.8, 8.9
and 8.10). For this, the Guidance listed below is available.
In a real life situation, daily exposure to different articles treated with the same active
substance may occur. Consequently, an aggregated exposure assessment may be
necessary. Uses with the same exposure pattern can be summarised to simplify the
aggregated exposure assessment. If an active substance is used in a large number of
different consumer articles, it is likely that a consumer is exposed from multiple uses. To
reflect this in an exposure assessment, it may be considered as a first step to compare
the acute exposure of single characteristic uses to a chronic AEL value.
Further Guidance:
 TNsG on Human Exposure to Biocidal Products (EU, 2007). This document
contains some models for exposure scenarios from treated articles in section
2.6.9. For scenarios not covered by the available models, the general principles
for secondary exposure assessment in the document should be followed in order
to build scenario-specific models;
 Guidance for Food Contact Materials (Commission Regulation (EU) No 10/2011).
This regulation defines test conditions for migration studies. The migration
studies give amounts of substances in food or per surface area. Consumer
exposure is then calculated using the migration results and assuming a 60kg
person consuming 1kg of food in contact with 6.0dm2 FCM in a day. The EFSA
Note for Guidance for petitioners presenting an application for the safety
assessment of a substance to be used in food contact materials prior to its
authorisation (EFSA, 2008) is currently under revision and should be consulted
when finished for current body weight and food intake default values. It should be
noted that only plastic materials are covered by the regulation. Other materials
should be assessed in line with the principles for plastic materials;
Suitable exposure assessment models for specific scenarios available from other sources
may be used for the assessment of treated articles, e.g. a generic risk assessment model
for insecticide treatment of mosquito nets and their subsequent use (WHO, 2004).
3 Part A: Dossier Requirements for Biocidal Products

BPR Annex III, Title 1, 6 Effectiveness against target organisms
NOTE to the reader:
The following section headings include a reference to the relevant section/point in
the BPR Annex for ease of cross reference.
3.1 Point 6 Effectiveness against target organisms

Authorisation will only be granted according to Art. 19 (1) b of the BPR if a biocidal
product is sufficiently effective. Thus, the data provided must show the efficacy of a
biocidal product or, where such claims are made in treated articles. The intended
function and the given use conditions must be reflected in the efficacy tests.
The efficacy assessment of a biocidal product is based on substantiating the efficacy
claims made for a product. The assessment is made on the product and its instructions
and conditions of use.
All requirements regarding efficacy outlined below equally apply also to the simplified
authorisation procedure (Article 20(1)(b) of the BPR).
For each product type and use area separately, the following information (sections 3.1.1
to 3.1.9) must be included.
3.1.1 Point 6.1 Function, e.g. fungicide, rodenticide, insecticide,

bactericide and mode of control e.g. attracting, killing, inhibiting
It is often necessary to describe the function of the biocidal product in more detail,
particularly if use in treated articles is intended. In many cases it is not sufficient to refer
only to terms (e.g. bacteriostatic, fungicidal, attracting) although they provide useful
clarification within the overall description. The function should be described in terms of a
problem formulation: which problem is caused by the unwanted organism? How does the
biocidal treatment prevent or solve the problem? It is hereby often essential to describe
the conditions of use and the type of material which is to be protected. Use conditions
and materials can often vary greatly and in this case it is necessary to define the use
conditions and materials for which the biocidal product is supposed to be effective.
In case of articles where the protection of humans or animals is intended, it is even more
crucial to describe the problem and the protection goal to describe the function. This is a
necessary precondition to evaluate the efficacy of such treatment.
3.1.2 Point 6.2 Representative organism(s) to be controlled and

products, organisms or objects to be protected
For an organism to be controlled provide both the common name and the scientific name
when possible and also the sex, strain and stadia where relevant and appropriate. In
cases where groups of organisms are to be controlled, generic names that are
representative of the group must be indicated (e.g. bacteria, flying insects, animal
fouling).
For groups that are not specifically addressed in BPR Guidance: Volume II (Parts B+C), it
may be useful to provide examples of relevant species within the stated group.
If relevant, indicate in which parts of EU the organisms to be controlled exist.
List the products, organisms or objects which are to be protected and against which
organisms or group(s) of organisms. Make it clear whether humans or animals must be
protected.
3.1.3 Point 6.3 Effects on representative target organisms.

The effects on the target organisms required for the claimed efficacy should be described
and specified for each use and method of application if these have different effects. For
microorganisms, it needs to be indicated whether the intended effect is biostatic or
biocidal for each use.
The dependence of the effect on the concentration of the active substance should be
indicated.
3.1.4 Point 6.4 Likely concentration at which the active substance will
be used
The likely use concentrations of active substance(s) and applied dose rate of product
should be stated for each use and method of application. When a dose range is
suggested an explanation should be given when to use the lower or upper limit. It should
be indicated and justified if the use concentrations are different in different parts of EU
and whether they should be different in different materials, for different use-conditions,
etc.
The dose rate used in the efficacy assessment and risk assessment should be consistent.
When a dose range is suggested efficacy should be demonstrated at the lower limit.
3.1.5 Point 6.5 Mode of action (including time delay)

The mode of action in terms of the biological, biochemical and physiological mechanisms
and biochemical pathways involved should be stated.
Information on time delay should be included, where applicable.
Where it is expected that there is a time delay before the effects start, information
should be provided to address this, for example insect growth regulators (e.g. larvicides)
that take some time to manifest their effect (e.g. on adult population of flies and
mosquitoes). Also conditions that influence on efficacy (of disinfectants or
preservatives), like temperature, humidity and other should be added. Where available,
the results of experimental studies must be reported.
Where it is known that in order to exert its intended effect the active substance must be
converted into a metabolite or degradation product following application or use of a
preparation containing it, justification should be submitted for why this metabolite or
degradation product is not considered to be the active substance. In addition, available
information relating to the formation of reactive metabolites or reaction products must
be provided. This information must include:
 The chemical name, empirical and structural formula, molecular mass, and CAS
and EC (EINECS, ELINCS or No Longer Polymers list) numbers if available;
 The processes, mechanisms and reactions involved;
 Kinetic and other data concerning the rate of conversion and if known the rate
limiting step; and
 Environmental and other factors effecting the rate and extent of conversion.
Indicate also if the actual active substance is the result of a combined action of different
products, when such a combination is necessary to achieve the intended effect (i.e. in
situ generated active substance).
3.1.6 Point 6.6 The proposed label claims for the product and, where
label claims are made, for treated articles
The directions for use and the claims made for the biocidal product are included in a
summary of the biocidal product characteristics (SPC) in accordance with Article 22(2)
(BPR).
A label claim is information which is provided to the user which describes the biocidal
effects that will result from using a biocidal product under its normal conditions of use
(i.e. when it is used at the recommended dose/application rate, by the recommended
application method(s) and in the appropriate areas, etc.). The product label can only
include claims that are in line with the authorised uses, as given in the SPC 6.
Label claims should be as specific as possible, or if more general claims (such as “fast
acting”) are made, then they should be further clarified in the PAR where possible (e.g.
“fast acting – acts within 5 minutes”). If no clarification is provided, the evaluating
Competent Authority should ask the applicant to specify the claim. A judgement as to
what a normal user would reasonably expect from the claim should be made. The
evaluation should be made according to this claim and the directions for use should be
taken into account.
Please also refer to the specific section for the different PTs in Vol II, parts B+C of the
efficacy guidance (e.g. Appendix 1 and 4 for disinfectants, chapter 5.5.6.1 for wood
preservatives, chapter 5.7.1.1.7 for antifoulings, chapter 5.6.2.4.1 “Norms and criteria”
for rodenticides) to understand which requirements and pass criteria apply for certain
claims. For preservatives, it needs to be made clear whether the claims refer to curative
or preservative effects. Marketing statements that are not related to the biocidal function
(e.g. new fragrance, better formula) are not subject to the efficacy evaluation and
should not be stated in the product application. The claims demonstrated become part of
the products authorisation.
3.1.7 Point 6.7 Efficacy data to support these claims,

Point 6.7 of Annex III to the BPR states that [….] including any available standard
protocols, laboratory tests or field trials used including performance standards where
appropriate and relevant.
Volume II, Parts B+C provide further elaboration in this area, including treated articles.
Product-type-specific guidance where available can be found in Parts B+C. Applicants are
advised to check for the future availability of new guidance.
The applicant must demonstrate that the biocidal product or treated article is effective
and suitable for its intended use when applied according to its instructions for use. This
can be confirmed by provision of data that may include laboratory studies, simulated-use
or semi-field test data or other relevant study data, provided that the test conditions
reflect instructed conditions of use.
For field studies the extent of the information required will vary depending on the
product-type and proposed use pattern. The data provided should include all appropriate
information that is necessary for an evaluation of the reported results. This generally
includes information on the harmful organism (e.g. relevance to the Member State in
which authorisation is sought) and relevant case-dependent information which can
include meteorological parameters (e.g. mean temperatures and rainfall), location
details or physico-chemical parameters of the system in which the biocidal product is
used.
6
See also: European Commission Note for Guidance Linking biocidal label claims and the product
authorisation CA-March17-Doc.4.3 – Final
For laboratory studies and field studies, practical aspects of designing and performing
tests on efficacy are described in the product-specific parts of Parts B+C.
The test method should measure a response and, as appropriate, an endpoint relevant
to the label claims. The method should employ an untreated control. However, this may
not be always possible for field studies.
Appendix 1 of this guidance provides a check-list for preservatives for the suitability of
the planned or submitted test.
Where earlier formulations of the product/treated article or other products/treated
articles containing the same active substances are cited as supporting evidence, all
relevant formulation details must be provided and the relevance of this evidence to the
current formulation must be fully justified, preferably through bridging efficacy studies.
The tests (and data generated) should be based on sound scientific principles and
practices. Although GLP is not required for efficacy studies, testing should be carried out
in accordance with a relevant quality standard, e.g. ISO 170257, ISO 90018 or GLP .
More detailed guidance on appropriate test methods is provided in Volume II Parts B+C .
3.1.8 Point 6.8 Any known limitations on efficacy

Provide possible restrictions or recommendations concerning the use of the product in
specific environmental or other conditions. State possible factors that can reduce the
efficacy, for instance hot, cold or humid environments or the presence of other
substances, in addition to the reasons for these. State if the product cannot be mixed or
used consecutively with, for example, other biocidal products or detergents, or if the use
of the product with other biocidal products is recommended.
3.1.8.1 Point 6.8.1 Information on the occurrence or possible occurrence of

the development of resistance and appropriate management strategies
Provide information on the occurrence or possible occurrence of the development of
resistance and appropriate management strategies, including also cross-resistance. This
information must be submitted even where it is not directly relevant to the uses for
which authorisation is sought or to be renewed (e.g. different species of harmful
organism), as it may provide an indication of the likelihood of resistance development in
the target population.
Where there is evidence or information to suggest that in commercial or experimental
use the development of resistance is likely, evidence must be generated and submitted
as to the sensitivity to the substance on the part of the populations of the harmful
organism concerned. In such cases a management strategy designed to minimise the
likelihood of resistance or cross-resistance developing in target species must be
provided. This should include possible recommendations concerning the avoidance of the
continuous use of the product to prevent the development of resistant strains in addition
to the reasons for these. It may be acceptable to make a reference to the CAR, however
if more recent or relevant information on the product is available this should be
provided. This is addressed in the TNsG on product evaluation (EU, 2008c) Appendix
6.29.
7 General requirements for the competence of testing and calibration laboratories

8 Quality management systems – requirements.
9See “related link” on the ECHA BPR webpage [https://echa.europa.eu/guidance-
documents/guidance-on-biocides-legislation]
3.1.8.2 Point 6.8.2 Observations on undesirable or unintended side effects e.g.

on beneficial and other non-target organisms
Provide observations on undesirable or unintended side effects. Provide observations
such as on adverse reaction to fastenings and fittings used in wood following the
application of a wood preservative, corrosion risk on sanitary fittings following
application of disinfectants, etc. Provide information on effects on beneficial and other
non-target organisms, only as far as this is not covered under Volume IV Sections 2 and
3.
Provide information on unnecessary suffering and pain for target vertebrates, where
relevant (PT14, 15, 17, 19, 20).
3.1.9 Point 6.9 Summary and evaluation

The findings on the effectiveness against target organisms (BPR Annex III, Title 1, 6.1-
6.8.2) are summarised and evaluated. Describe how the provided tests demonstrate the
efficacy against all the target organisms at the use concentration and use conditions
instructed (e.g. application method, contact time).
When authorisation is sought for a product family the evaluation should be done per
meta SPC, not per product.
3.2 Point 7 Intended uses and exposure

The SPC (Summary of the Biocidal Product Characteristics) is the summary document for
the biocidal product which contains administrative information, information of product
classification and labelling, authorised uses and direction for use. An example of the
label and instruction for use must be provided for each application for product
authorisation10,11. The information indicated on the label, instructions for use 12 and other
information sources (e.g. web pages) should be consistent with the information in the
SPC.
Based on the conclusions of the efficacy assessment the following information should be
included in the Section 4 Authorised uses of the draft SPC: any uses of a biocidal
product, which clearly describe the target organism(s), field(s) of use, application
method(s), application rate(s), application conditions where relevant (e.g. use under
high soiling, at 4°C) and frequency and category(ies) of users. Instructions for use
should be given which can be use specific, meta- SPC specific, or general for the whole
SPC.
Considering the exposure and risk assessment the draft SPC also includes all risk
mitigation measures which should be considered for relevant use of product, particularly
of likely direct or indirect effects, resistance, first aid instructions and emergency
measures to protect environment, also instructions for safe disposal of the product and
its packaging and conditions of storage of the product. These instructions should be
given which can be use specific, meta- SPC specific, or general for the whole SPC.
10
Label(s) must be provided in accordance with Annex III, Section 12 of BPR. Please note that at the same
time the biocidal product labels are not part of the product authorisation.
11
See also Note for guidance (CA-Nov15-Doc.4.2- Final) Submission of example labels, instructions for use,
safety data sheets and models or drafts of the packaging, labelling and leaflets within an application for
product authorisation - /CircaBC/SANTE/BPR - Public/Library/documents_finalised
12
Article 69(2) of BPR.
3.2.1 Point 7.1 Field(s) of use envisaged for biocidal products and,
where appropriate, treated articles
Please follow guidance in section 2.2.1 of this guidance.
3.2.2 Point 7.2 Product-type

3.2.3 Point 7.3 Detailed description of intended use pattern(s) for

biocidal products and, where appropriate, treated articles
3.2.4 Point 7.4 User e.g. industrial, trained professional, professional

or general public (non-professional)
The description of the user on the authorised label might be different from the user
categories described under BPR Point 7.4, due to the national policy and laws.
3.2.5 Point 7.5 Likely tonnage to be placed on the market per year
and where relevant, for different use categories
An estimate of the quantity of the product or treated article, respectively, placed or to be
placed on the EU market by the applicant (i.e. imported or produced) per year. The
quantities for biocidal use and in which product-types, and where relevant, for the
intended major use categories within each of the product-types. The quantities for use
other than as a biocide should be indicated, if available. In case of the renewal of
authorisation, tonnage data should cover the last three years. For new products, not
previously marketed, production plans covering the next three years after authorisation
should be provided.
Where relevant, this information can be added to the confidential annex of the
application.
3.2.6 Point 7.6 Method of application and a description of this method

The method of application of product in different uses should be explained. If the product
is to be diluted, this should be stated and recommendations on how to do this should be
given (e.g. 3 gram product per 5 litre water). A description of the application technique
(e.g. dipping, spreading, spraying, automatic/manual dosing etc.) should be included. If
additional substances have to be added to the solution, their dosages must also be
given.
If specific technical device will be used together with the product, a description of this
device should be provided.
If a device is used to produce the active substance in situ and dose it directly,
information should be provided on control and safety measures to avoid over and under
dosing.
The devices used to generate the active substance in situ themselves are not covered by
the provision of BPR and consequently are not subject to the authorisation.
3.2.7 Point 7.7 Application rate and if appropriate, the final

concentration of the biocidal product and active substance in a treated
article or in the system in which the preparation is to be used, e.g.
cooling water, surface water, water used for heating purposes.
The recommended dose of the product and the active substance per object should be
stated (e.g. per surface area of the material to be protected or as a concentration in a
water system).
For disinfectants applied in order to disinfect surfaces, information on the amount of
product applied per m2 should be provided. If the product is to be diluted, the substance
used for dilution and the final concentration of the product as well as the active
substance in the solution - as a percentage - must be stated.
For product-type 21, the final concentrations of each biocidal component in the
antifouling coating layer of the antifouling product and in addition the thickness of the
film should also be given.
3.2.8 Point 7.8 Number and timing of applications, and where

relevant, any particular information relating to geographical location or
climatic variations including necessary waiting periods, clearance times,
withdrawal periods or other precautions to protect human and animal
health and the environment
Indicate the recommended duration of application and possible re-applications including
estimated life-time of the treated article if relevant.
Describe, where relevant, how the applications should differ in different parts of the EU
or under otherwise differing use-conditions.
The following product-type-specific guidance should be followed if applicable:
 For disinfectants of Main Group 1, potential information on effects of temperature
and humidity on the frequency of application must be supplied where relevant.
The contact time needed to provide sufficient efficacy should be stated. The
waiting period and, if applicable, the necessity of rinsing or wiping to avoid the
presence of unacceptable residues from treated equipment in food or feed
products should be given.
 For material preservatives of product-types 6, and 7 to 10, instructions on the
minimum drying time or time to reach resistance to leaching (fixation) of the
product in the material treated has to be described. Information on the effects of
e.g. temperature and humidity on drying or fixation has to be given, i.e. when the
treated material is dry enough for safe exposure of humans and the environment.
Furthermore, when possible, a qualitative or quantitative method should be
stated for determining that the proper drying or resistance to leaching has been
achieved.
 For product-types 11 and 12, when used in an open system with process water,
information on the minimum dilution or treatment time for the active substance in
waste water should be given in order to assure a sufficient degree of degradation
or dilution before it is released to a water course to protect aquatic organisms
from harmful effects.
 For pest control products of Main Group 3, for products used in e.g. fumigation,
clearance times sufficient to protect bystanders etc. should be given.
 For molluscicides (product-type 16) and piscicides (product-type 17), necessary
waiting periods should be given to prevent harm or dislodging of unacceptable
residues from treated tanks or basins for e.g. the subsequent batch of
aquaculture.
 For product-type 21, instructions on the minimum drying time of the coating and
information on the effects of for instance, temperature and humidity on drying
have to be given, i.e. it should be indicated when the coating is dry enough to be
ready for launching and whether the coating should be washed before launching
in order to reduce the primary release into the aquatic environment. Furthermore,
a method for ensuring that a proper coating has been achieved should be given.
3.2.9 Point 7.9 Proposed instructions for use

Any instructions for the end user for proper use of the product should be given here.
The applicant should consider and define the parameters necessary for the effective use
of the biocidal product, for example where this is relevant for the respective product:
 The methods by which the biocidal product is employed (for example: spray,
wipe, disperse);
 The areas where the product should be applied (e.g. insecticide under
refrigerator, in the cracks and crevice, with a bandwidth of 20 cm);
 The necessary preparatory measures, e.g. clean surfaces;
 The time that the biocidal product should be allowed to be in contact with the
target (for example: minutes, hours, days);
 The frequency of application or re-application;
 The temperature range within which the biocidal product should be used;
 The dose rate;
 The necessary precautionary measures.
3.2.10 Point 7.10 Exposure data in conformity with Annex VI of this

Regulation
According to Annex VI on the common principles for the evaluation of dossiers for
biocidal products, an exposure assessment needs to be carried out for human and
environmental populations for which exposure to a biocidal product occurs or can
reasonably be foreseen.
For further guidance on exposure assessment of biocidal products see Parts B+C
Evaluation and Assessment of Volumes III and IV of the BPR Guidance.
3.2.10.1 Point 7.10.1 Information on human exposure associated

with production and formulation, proposed/expected uses and disposal
Sufficient information on exposure to the biocidal product likely to occur during the
proposed conditions of use must be submitted. The information should include all
relevant stages of production and formulation and of use and all possible exposure
routes. Actual exposure data and/or calculations using recommended models are
acceptable. Test reports of any studies conducted because an exposure of the biocidal
product on humans through the particular route is possible must be submitted. An
expert judgment is needed to decide if any other studies are required (see section 1.2,
point 4 of the BPR Guidance, Volume I, Part A: Information Requirements). A starting
point is assessment of human exposures to biocides, see BPR Guidance, Volume III
Human Health Parts B+C.
Please also follow guidance in section 2.2.6.1 of this guidance.
3.2.10.2 Point 7.10.2 Information on environmental exposure

associated with production and formulation, proposed/expected uses
and disposal
Please follow guidance in section 2.2.6.2 of this guidance.

including leaching data (either laboratory studies or model data)
Please follow guidance in section 2.2.6.4 of this guidance.
3.2.10.4 Point 7.10.4 Information regarding other products that the

product is likely to be used together with, in particular the identity of
the active substances in these products, if relevant, and the likelihood of
any interactions
Possible incompatibility with any products or active substances should be mentioned.
REFERENCES AND BACKGROUND DOCUMENTS

ECHA. (n.d.). Guidance on information requirements and chemical safety assessment
Chapter R.6: QSARs and grouping of chemicals.
ECHA. (n.d.). Guidance on intermediates.
ECHA. (n.d.). Guidance on the application of the CLP criteria.
EU. (2003). Technical Guidance Document (TGD) on Risk Assessment in support of
Commission Directive 93/67/EEC on Risk Assessment for new notified substances,
Commission Regulation (EC) No 1488/94 on Risk Assessment for existing
substances and Directive 98/8/EC of the.
EU. (2008a). Technical Guidance Document in support of the of Directive 98/8/EC
concerning the placing of biocidal products on the market. Guidance on Data
Requirements for active substances and biocidal products. Short title: TNsG Data
Requirements.
EU. (2008b). The Technical Notes for Guidance on Dossier preparation including
preparation and evaluation of study summaries under Directive 98/8/EC
Concerning the Placing of Biocidal Products on the Market. Short title: TNsG on
Dossier Preparation of Dossiers and St.
EU. (2008c). TNsG on product evaluation.
EU. (2009b). Technical Notes for Guidance on Product Evaluation Appendices to Chapter
7 Product Type 14 Efficacy Evaluation of Rodenticidal Biocidal Products.
EU. (2011a). Manual of Technical Agreements of the Biocides Technical Meeting (MOTA).
Version 4.
EU. (2012a). Technical Notes Guidance EU Evaluation Manual for the Authorisation of
Biocidal Products. Short title: Evaluation manual.
EU. (2012b). TNsG on Products Evalation. (Revised Appendix to Chapter 7) Guidance
Efficacy Evaluation of Insecticides PT 18 and 19. Ca-Dec12-Doc 6.a.)
https://circabc.europa.eu/w/browse/9f8f7f60-764b-4833-9989-a3b6d687dcc6.
FAO. (2010). Manual on the Development and Use of FAO and WHO Specifications for
Pesticides, second revision.
OECD. (2000a). Guidance Document on Aquatic Toxicity Testing of Difficult Substances
and Mixtures. Series on Testing and Assessment, No 23.
OECD. (2007b). Analysis and Assessment of Current Protocols to Develop Harmonized
Test Methods and Performance Standards for the Efficacy Testing of Treated
Articles/Treated Materials. ENV/JM/MONO(2007)4.
OECD. (2008d). Guidance document on the evaluation of the efficacy of antimicrobial
treated articles with claims for external effects, ENV/JM/MONO(2008)27.
OECD. (2012b). Guidance document for demostrating efficacy of pools and spa
disinfectants in laboratory and field testing. Series on Testing and Assessment No
170. Series on Biocides No 4. ENV/JM/MONO(2012)15.
UN. (2009). Recommendations on the Transport of Dangerous Goods. Manual of Tests
and Criteria. ST/SG/AC.10/11/Rev.5. (UN-MTC). New York and Geneva.
Appendix 1 Check list for efficacy tests preservatives
Possible Test not

Question
answers acceptable if
Is the identity of the tested BP clear? + or - -
Is the tested product the reference BP/the BP + or - Usually not if -
applied for?
Is the tested material relevant for the intended PT Written Expert
and use?1 justification judgement
Is the loading/ + or - -
concentration of the active substance in its matrix
< what is stated in the use descriptions?
Is the test-protocol used relevant for the function Written Expert
of the representative BP/the BP applied for? justification judgement
Are the tested organisms relevant for the intended + or - -
use? 2
Is the test protocol depicting a relevant end + or - -
point?3
Have untreated controls + or - -
been tested?4
Have the controls (i.e. growth) been validated Quantification Expert
according to a relevant guidance or standard judgement
document?
Has the intended inhibition/killing/controlling effect + or - -
of the harmful organisms occurred and does it fulfil
the requirements set by a relevant guidance or
standard document?
Has statistical significance of the results been + or - -
calculated?5
1i.e. the material becomes deteriorated by microbial growth under the given use conditions
2i.e. in which way do they deteriorate the matrix?
3i.e. in preventive use: inhibition of deterioration by harmful organisms; in curative use:
killing/controlling effect of harmful organisms
4Untreated controls including: the same material, the same product formulation without the active
substance
5 Where statistical analysis is possible, as a minimum, a mean and standard deviation should be
given. If applicable, statistical calculations can be done according to Annex V of IBRG
(www.ibrg.org) PDG16-007.2 Tier 1 Basic efficacy for biocidal Active Substances used to preserve
Aqueous based products.
ANNANKATU 18, P.O. BOX 400,

FI-00121 HELSINKI, FINLAND
ECHA.EUROPA.EU

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GUIDANCE

Guidance on the Biocidal Products Regulation

Guidance on the Biocidal Products Regulation: Volume II: Efficacy - Part A:

European Chemicals Agency

Mailing address: P.O. Box 400, FI-00121 Helsinki, Finland

Version Comment Date

Version 1.0 First edition June 2013

Version 1.1 Corrigendum: November

- Minor editorial changes

 Update to Sections 2 and 3 relating to Point 6 of the

 Addition of sections 2.2 & 3.2 - “Point 7 Intended Uses

 To amend the formatting and numbering of all sections

Figure 1: BPR guidance structure

LEGAL NOTICE ................................................................................................... 2

NOTES to the reader:

BPR Guidance Volume + section

BPR Guidance Volume + section

Standard term Explanation

1 Part A: Introduction to the Guidance on

1.1 General structure of the guidance on information

1.1.1 Information requirements in general

1.1.2 Comparison of BPD-BPR

Annex II Annex III

Annex II Annex III

Figure 2: Structure of data/information requirements under the BPD and the

Table 3 Three-column- structure of BPR information requirements in Annexes II

Specific rules for adaptation

1.1.3 Volume II Part A: Document structure

1.2 Guiding principles with regard to information requirements

Council Regulation (EC) No 1907/2006 and Council Regulation (EC) No

Human Health and Environment. A study with a reliability indicator of 3 or 4

1.3 On the use of additional Guidance documents

1.3.1 Existing biocides Guidance and other relevant documents

1.3.2 REACH Guidance

1.3.3 CLP Guidance

1.4 General guidance on generating new information

or as obtained by a production process. This includes any additive necessary to preserve

compounds has been published Guidance on intermediates. The Guidance provided in

1.5 Guidance on non-submission of information

1.6 Testing of metabolites and transformation products

1.7 Background documents

bibliographic website: http://eur-lex.europa.eu. or ECHA website:

1.8 Sources of test methods and standards

2 Part A: Dossier Requirements for Active Substances

BPR Annex II, Title 1, 6 Effectiveness against target organisms

2.1 Point 6 Effectiveness against target organisms

2.1.1 Point 6.1 Function, e.g. fungicide, rodenticide, insecticide,

2.1.2 Point 6.2 Representative organism(s) to be controlled and

2.1.3 Point 6.3 Effects on representative target organism(s)

2.1.5 Point 6.5 Mode of action (including time delay)

2.1.6 Point 6.6 Efficacy data to support these claims on biocidal

2.1.7 Point 6.7 Any known limitations on efficacy

2.1.7.1 Point 6.7.1 Information on the occurrence or possible occurrence of

2.1.7.2 Point 6.7.2 Observations on undesirable or unintended side-effects,

2.2 Point 7 Intended uses and exposure

2.2.2 Point 7.2 Product-type(s)

2.2.3 Point 7.3 Detailed description of the intended use pattern(s)

2.2.4 Point 7.4 Users, e.g. industrial, trained professional,